Grover's Disease, Psoriasis Vulgaris
Conditions
Brief summary
This study will use Blue-light Photo-therapy to treat patients with psoriasis vulgaris and Grover's Disease.
Interventions
DEVICEBlue light phototherapy
Phototherapy- Wavelength: 417±15 nm
Sponsors
T-Cellerate LLC
Northwestern University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
1. Patient's aged 18-89 at time of enrollment 2. Previous diagnosis of psoriasis vulgaris or Grover's disease
Exclusion criteria
1. All Groups: Subjects who are younger than 18 years of age or older than 90 years of age 2. Patients who have received topical or systemic treatment within the prior 2 weeks of planned phototherapy 3. Patients prescribed any of the following drugs for issues not related to their psoriasis or Grover's disease * topical steroids * calcineurin inhibitors * methotrexate * retinoids * biologic agents 4. Unable to schedule phototherapy sessions 5. We will not recruit the following populations: adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, prisoners and other vulnerable populations.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Blue Light Therapy for Patients With Grover's Disease | Time Frame: 5 weeks | Demonstrate preliminary skin efficacy as measured by lesion count |
| Assess User Experience With the Dermatology Life Quality Index (DLQI) Pre and Post-treatment. | Time Frame: 5 weeks | The DLQI is a questionnaire with 10 questions. The maximum score is 30 and minimum is 0. The higher the score, the more quality of life is impaired. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Adult Treatment Arm Adults enrolled in the study will receive treatment (blue light phototherapy) on one area of their body affected by psoriasis or Grover's disease. The treatment area (restricted by size of the device) will be compared to untreated areas affected by disease on the same patient.
Blue light phototherapy: Phototherapy- Wavelength: 417±15 nm | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | Adult Treatment Arm |
|---|---|
| Age, Continuous | 63 years STANDARD_DEVIATION 14 |
| Race/Ethnicity, Customized White | 11 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
Assess User Experience With the Dermatology Life Quality Index (DLQI) Pre and Post-treatment.
The DLQI is a questionnaire with 10 questions. The maximum score is 30 and minimum is 0. The higher the score, the more quality of life is impaired.
Time frame: Time Frame: 5 weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Adult Treatment Arm | Assess User Experience With the Dermatology Life Quality Index (DLQI) Pre and Post-treatment. | Baseline | 4.3 score on a scale |
| Adult Treatment Arm | Assess User Experience With the Dermatology Life Quality Index (DLQI) Pre and Post-treatment. | End of Treatment | 2.3 score on a scale |
Primary
Efficacy of Blue Light Therapy for Patients With Grover's Disease
Demonstrate preliminary skin efficacy as measured by lesion count
Time frame: Time Frame: 5 weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Adult Treatment Arm | Efficacy of Blue Light Therapy for Patients With Grover's Disease | Baseline | 27 lesion count |
| Adult Treatment Arm | Efficacy of Blue Light Therapy for Patients With Grover's Disease | End of Treatment | 6 lesion count |